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FDA 510(k)

REVISION PROTHESIS

K-Number: K110837 · 2011-04-22

ApplicantSmith & Nephew, Inc.
Decision Date2011-04-22
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REVISION PROTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2011-04-22 under 510(k) number K110837. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REVISION PROTHESIS?

REVISION PROTHESIS is a medical device that received FDA 510(k) clearance on 2011-04-22. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K110837.

When did REVISION PROTHESIS receive FDA 510(k) clearance?

REVISION PROTHESIS received FDA 510(k) clearance on 2011-04-22, under 510(k) number K110837.

Who is the listed applicant for REVISION PROTHESIS?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REVISION PROTHESIS?

The FDA product code for REVISION PROTHESIS is JWH.

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Other records listing Smith & Nephew, Inc. as applicant

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Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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